InfertilityNCT04602143
Effect of Testosterone Pretreatment in POR
A study testing Testosterone gel in people with Infertility, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
This study compared the therapeutic effect of 4- and 6-week TTG application before controlled ovarian hyperstimulation (COH) in POR. Read more about this study
- Who is it for?
- Ages 20 to 47 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Testosterone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Feb 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- donated gamete IVF cycles
- Thyroid disease
- Liver and kidney dysfunction
- Abnormal genitalia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effect of Prolonged Testosterone Pretreatment in Women With Poor Ovarian Response: a Randomized Control Trial
This study compared the therapeutic effect of 4- and 6-week TTG application before controlled ovarian hyperstimulation (COH) in POR.
Read the detailed description
This randomized control trial (RCT) was conducted between January 2018 and September 2019 at the National Center for Reproductive Medicine, Hanoi, Vietnam. The eligibility of a total of 165 women with POR, undergoing IVF treatment, to be enrolled in the study was assessed. Inclusion criteria included patients who met at least two of the following criteria: (i) having one previous IVF/ intracytoplasmic sperm injection (ICSI) cycle with ≤ 3 oocytes recruited; (ii) AFC ≤ 5-7; and (iii) anti-Mullerian hormone (AMH) ≤ 0.5 - 1.1 ng/mL were enrolled. Exclusion criteria included donated gamete IVF cycles, thyroid disease, liver and kidney dysfunction, and abnormal genitalia. After screening, eligible patients were randomly allocated into two TTG intervention groups (4-week and 6-week groups) and one control group through a manual lottery. Allocation concealment was by sequentially numbered, opaque, sealed envelopes. All participants were blinded to group assignment, but researchers were not blinded.
Serum testosterone are measured before treatment. Durations of androgen supplement are 4 or 6-weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.
After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols.
Patients will be followed up at least until 12th week of gestation, if they have positive pregnancy test after embryo transfer.
Data were analyzed using STATA software version 14.0 (Stata Corporation, College Station, TX, USA). Data were analyzed on an intention-to-treat basis. Proportions, means, and standard deviations (SDs) were examined and presented for selected baseline variables by treatment group. Comparisons of baseline characteristics and outcomes by treatment group were performed with the use of ANOVA for continuous variables and a chi-square test for proportions. A Bonferroni correction was used for multiple testing, in which the resulting P-value was multiplied by the number of tests that measured similar constructs. Multivariable logistic regressions were used to quantify the effects of the treatment group, adjusted for all potential confounders including maternal age, body mass index (BMI), infertility duration, primary or secondary infertility, and history of IVF treatment. All statistical tests were two-sided, and P values < 0.05 were considered statistically significant.
- Conditions
- Infertility
- Being tested
- Testosterone gel
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called Androgel 1% Transdermal Gel
Apply 12.5mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 4 or 6 weeks until next IVF treatment.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel 4 weeks | Experimental | Patients with low ovarian reserve received 4-week TTG application before controlled ovarian hyperstimulation. Receives: Drug: Testosterone gel |
| Testosterone gel 6 weeks | Experimental | Patients with low ovarian reserve received 6-week TTG application before controlled ovarian hyperstimulation. Receives: Drug: Testosterone gel |
| Control group | No intervention | Patients with low ovarian reserve received no medication before controlled ovarian hyperstimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
The main outcomes of our study were the total number of retrieved
Measured: 30 minutes after oocyte retrieval complete
Secondary outcomes (3)
Pregnancy rates.
Pregnancy was defined as positive when the serum beta-hCG level was ≥ 50 IU/L
Measured: 14 days after embryo transfer
clinical pregnancy rates.
Clinical pregnancy was defined as the presence of a gestational sac identified by transvaginal ultrasound
Measured: 4 weeks after embryo transfer
Ongoing pregnancy rates
Ongoing pregnancy was defined as a viable intrauterine pregnancy after 12 weeks of gestation.
Measured: after 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start16 Feb 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital of Obstetrics and Gynecology
- Responsible party
- Sponsor
- Investigators
- Hung S Ho, MD, PhD, Study director, Hanoi Medical UniversityTien V Nguyen, MD, PhD, Study chair, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602143
- Sponsor's protocol ID
- hoangquochuy, MD
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Prolonged Testosterone Pretreatment in Women With Poor Ovarian Response: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04602143
- Acronym / sponsor ID
- hoangquochuy, MD
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- National Hospital of Obstetrics and Gynecology
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared the therapeutic effect of 4- and 6-week TTG application before controlled ovarian hyperstimulation (COH) in POR.
Detailed description
This randomized control trial (RCT) was conducted between January 2018 and September 2019 at the National Center for Reproductive Medicine, Hanoi, Vietnam. The eligibility of a total of 165 women with POR, undergoing IVF treatment, to be enrolled in the study was assessed. Inclusion criteria included patients who met at least two of the following criteria: (i) having one previous IVF/ intracytoplasmic sperm injection (ICSI) cycle with ≤ 3 oocytes recruited; (ii) AFC ≤ 5-7; and (iii) anti-Mullerian hormone (AMH) ≤ 0.5 - 1.1 ng/mL were enrolled. Exclusion criteria included donated gamete IVF cycles, thyroid disease, liver and kidney dysfunction, and abnormal genitalia. After screening, eligible patients were randomly allocated into two TTG intervention groups (4-week and 6-week groups) and one control group through a manual lottery. Allocation concealment was by sequentially numbered, opaque, sealed envelopes. All participants were blinded to group assignment, but researchers were not blinded.
Serum testosterone are measured before treatment. Durations of androgen supplement are 4 or 6-weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.
After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols.
Patients will be followed up at least until 12th week of gestation, if they have positive pregnancy test after embryo transfer.
Data were analyzed using STATA software version 14.0 (Stata Corporation, College Station, TX, USA). Data were analyzed on an intention-to-treat basis. Proportions, means, and standard deviations (SDs) were examined and presented for selected baseline variables by treatment group. Comparisons of baseline characteristics and outcomes by treatment group were performed with the use of ANOVA for continuous variables and a chi-square test for proportions. A Bonferroni correction was used for multiple testing, in which the resulting P-value was multiplied by the number of tests that measured similar constructs. Multivariable logistic regressions were used to quantify the effects of the treatment group, adjusted for all potential confounders including maternal age, body mass index (BMI), infertility duration, primary or secondary infertility, and history of IVF treatment. All statistical tests were two-sided, and P values < 0.05 were considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel 4 weeks | Experimental | Drug: Testosterone gelPatients with low ovarian reserve received 4-week TTG application before controlled ovarian hyperstimulation. |
| Testosterone gel 6 weeks | Experimental | Drug: Testosterone gelPatients with low ovarian reserve received 6-week TTG application before controlled ovarian hyperstimulation. |
| Control group | No intervention | –Patients with low ovarian reserve received no medication before controlled ovarian hyperstimulation. |
Who may qualify
- Ages
- 20 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- donated gamete IVF cycles
- Thyroid disease
- Liver and kidney dysfunction
- Abnormal genitalia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gelAlso: Androgel 1% Transdermal GelApply 12.5mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 4 or 6 weeks until next IVF treatment. | Drug | Testosterone gel 4 weeks, Testosterone gel 6 weeks |
Primary outcome
Number of oocytes retrieved
Time frame: 30 minutes after oocyte retrieval complete
The main outcomes of our study were the total number of retrieved
3 secondary outcomes
Pregnancy rates.
Time frame: 14 days after embryo transfer
clinical pregnancy rates.
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rates
Time frame: after 12 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung S Ho, MD, PhD study director
Hanoi Medical University
Tien V Nguyen, MD, PhD study chair
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone gel in people with Infertility, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved (time frame: 30 minutes after oocyte retrieval complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.